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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

OXYGEN: 1,861 Adverse Event Reports & Safety Profile

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1,861
Total FAERS Reports
307 (16.5%)
Deaths Reported
762
Hospitalizations
1,861
As Primary/Secondary Suspect
205
Life-Threatening
39
Disabilities
Pacific Island Medical, Inc.
Manufacturer
Prescription
Status

Route: RESPIRATORY (INHALATION) · Manufacturer: Pacific Island Medical, Inc. · FDA Application: 205712 · HUMAN PRESCRIPTION DRUG · FDA Label: Available

First Report: 19830905 · Latest Report: 20250801

What Are the Most Common OXYGEN Side Effects?

#1 Most Reported
Dyspnoea
243 reports (13.1%)
#2 Most Reported
Thermal burn
160 reports (8.6%)
#3 Most Reported
Intentional product misuse
146 reports (7.8%)

All OXYGEN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Dyspnoea 243 13.1% 29 136
Thermal burn 160 8.6% 24 85
Intentional product misuse 146 7.9% 51 73
Off label use 140 7.5% 33 63
Accident 132 7.1% 61 49
Epistaxis 132 7.1% 8 59
Oxygen saturation decreased 116 6.2% 12 58
Headache 115 6.2% 8 55
Drug ineffective 111 6.0% 18 72
Cough 107 5.8% 7 50
Diarrhoea 88 4.7% 7 41
Dizziness 83 4.5% 5 40
Nausea 81 4.4% 6 38
Foetal exposure during pregnancy 77 4.1% 2 14
Pneumonia 75 4.0% 9 65
Hypoxia 74 4.0% 22 35
Fatigue 66 3.6% 6 32
Malaise 65 3.5% 5 38
Hypotension 64 3.4% 15 38
Death 63 3.4% 63 18

Who Reports OXYGEN Side Effects? Age & Gender Data

Gender: 56.7% female, 43.3% male. Average age: 56.8 years. Most reports from: US. View detailed demographics →

Is OXYGEN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 2 2 0
2004 1 1 0
2006 1 0 0
2007 1 0 1
2008 1 0 1
2009 6 2 2
2010 7 0 0
2011 6 2 4
2012 9 1 3
2013 4 1 1
2014 52 4 19
2015 87 13 30
2016 53 20 24
2017 52 10 31
2018 71 14 45
2019 30 6 19
2020 29 2 12
2021 85 16 54
2022 51 7 27
2023 56 4 24
2024 69 10 38
2025 28 3 6

View full timeline →

What Is OXYGEN Used For?

IndicationReports
Product used for unknown indication 799
Oxygen therapy 85
Chronic obstructive pulmonary disease 72
Dyspnoea 47
Covid-19 41
Respiratory failure 39
Maintenance of anaesthesia 34
Hypoxia 33
Accidental exposure to product 23
Oxygen saturation decreased 23

OXYGEN vs Alternatives: Which Is Safer?

OXYGEN vs OXYMETAZOLINE OXYGEN vs OXYMORPHONE OXYGEN vs OXYQUINOLINE OXYGEN vs OXYTOCIN OXYGEN vs OXYTROL FOR WOMEN OXYGEN vs OZANIMOD OXYGEN vs PACLITAXEL OXYGEN vs PACRITINIB OXYGEN vs PALBOCICLIB OXYGEN vs PALIPERIDONE

Official FDA Label for OXYGEN

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Mixed drink

Dosage & Administration

Water 99.9971%, Oxygen 0.0029% (29mg/L, When filling up with water)

Warnings

Warning For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx ONLY. Uninterrupted use of high concentrations of oxygen over a long duration, without monitoring its effect on oxygen content of arterial blood, may be harmful. Do not attempt to use on patients who have stopped breathing unless used in conjuction with resuscitative equipment. Keep out of reach of children. Federal law requires that this container be refilled with oxygen USP only by establishments registered as a drug manufacturer in accordance with the Federal Food, Drug and cosmetic Act. DANGER: MAY CAUSE OR INTENSIFY FIRE; OXIDIZER CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. Do not handle until all safety precaustions have been read and understood. Keep and store away from clothing and other combustible materials. Keep valves and fittings free from grease and oil. Use and store only outdoors or in a well-ventilated place. In case of fire, stop leak if safe to do so. UUse a back flow preventive device in the piping. Use only with equipment of combustible materials of construction and rated for cylinder pressure. Use only with equipment cleaned for Oxygen service and rated for cylinder pressure. Open valve slowly. Close valve after each use and when empty. Protect from sunlight when ambient temperature exceeds 52 C (125F). Read and follow the Safety Data Sheet (SDS) before use. CAS 7782-44-7 DO NOT REMOVE THIS PRODUCT LABEL.

Fire Protection

Service, Inc. 8050 Harrisburg Blvd. Houston TX 77012 WWW.FPS-USA.COM 713-924-9600

Active Ingredient

Active Ingredients Oxygen

Inactive Ingredients

Inactive ingredients: Water